BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    THERAPLAN PLUS

    MDR report key: 127867 · Received October 20, 1997

    Report

    Report Number
    9610077-1997-00010
    Event Type
    Malfunction
    Date Received
    October 20, 1997
    Date of Event
    September 25, 1997
    Report Date
    October 16, 1997
    Manufacturer
    THERATRONICS INTERNATIONAL LTD.
    Product Code
    IWB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIST

    Narratives

    Description of Event or Problem · 1

    WHEN A PLAN IS BEING PREPARED WITH THE GANTRY AT 90 OR 270 AND COUCH AT 90 OR 270, THE SSD AND DEPTH USED FOR CALCULATION WILL CORRESPOND TO THE BEAM ENTERING ON THE FIRST SLICE. THIS WILL RESULT IN SUB-OPTIMAL CALCULATION ACCURACY IF THESE SET-UP CONDITIONS ARE USED WITH A VERTEX FIELD THAT ENTERS ON A SLICE OTHER THAN THE FIRST SLICE. THE MORE ACCURATE ENTRY-POINT SDD AND DEPTH ARE USED FOR CALCULATION FOR GANTRY ANGLES ARE OFFSET BY AT LEAST 0.5 DEGREES FROM 90 OR 270.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 THERAPLAN PLUS RADIATION TREATMENT PLANNING SYSTEM IWB THERATRONICS INTERNATIONAL LTD. THERAPLAN PLUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other